PRE-LAUNCH TEAM ROLES AND RESPONSIBILITIES

In advance of a major product launch, a pharmaceutical manufacturer needs to establish a team of specialists covering all disciplines within the company, including not only R&D and marketing but also production, finance, legal and regulatory affairs. All too often, however, the pre-launch teams are actually established only when the molecule has reached the late Phase III clinical trial stage, when the team members can function only as living data banks for the marketing people, according to Philippe Proost, European director within the UCB group's pharmaceuticals division.

In companies where the launch team has been set up when the product is in early Phase II trials, however, all team members will benefit from the techniques and skills of the others at all stages of its development, Mr Proost told IIR Ltd's recent international pharmaceutical marketing conference in London (Marketletter June 7). Moreover, he added, the early establishment of the team is an excellent way of avoiding the common "queuing" syndrome under which, because of the "partitions" existing between the various departments and disciplines in most companies, a department will start looking at a particular problem only when the dossier has been passed on to it. This early, multi-discipline concomitant approach makes it possible to shorten lead times drastically, said Mr Proost.

He then turned to the role each discipline should play. While R&D should obviously be committed to providing, as soon as possible, all basic clinical information that will enable the registration file to be acceptable, it can also do much more, he told the meeting. If the R&D department agrees to play the dual role of being both an ambassador and an information officer, it will play a key part in the product team, he said. Not only because it will be able to identify whether the product's positioning is correct and acceptable, but also by providing the information necessary to avoid registration delays by ensuring that the final registration file will be acceptable to the authorities. The production team will be able to seek confirmation, through the normal company channels, that the proposed registration strategy fits local requirements.